CLIA Certificate Of Waiver

CLIA '88 is the Clinical Laboratory Improvement Amendments of 1988. CLIA '88 is a series of federal laws regulating laboratory testing that were enacted to ensure high quality, reliable, safe and accurate testing in laboratories of all types and sizes throughout the United States. It established new standards for laboratory personnel, quality control and quality assurance based on the complexity and risk of the tests performed. Laboratory tests are classified into one of three categories based on the complexity: waived, moderate complexity, and high complexity. The Cholestech LDX System is in the waived category. Even though the LDX is a waived piece of equipment, you still must obtain a "CLIA certificate of waiver" to perform tests on the LDX.